NCT07561229

Brief Summary

The purpose of this study is to understand how different areas of the cerebellum (a part of the brain) control different functions and how they can be influenced by non-invasive brain stimulation. While researchers know that repetitive Transcranial Magnetic Stimulation (rTMS) can have positive effects on conditions like stroke and schizophrenia, they do not yet fully understand which specific stimulation settings work best or which exact parts of the cerebellum should be targeted for different symptoms. This study compares the effects of stimulation on two specific regions:

  • Lobule VIII: Linked to movement and motor learning.
  • CRUS I/II: Linked to attention, thinking (cognition), and predicting the timing of events.By comparing these areas, researchers hope to gain the information needed to develop better treatments for neurological and psychiatric disorders. This is a randomized, double-blind study involving 40 healthy volunteers. Participants will be split into two groups:
  • Group 1: Receives "exciting" (activity-increasing) stimulation.
  • Group 2: Receives "inhibiting" (activity-decreasing) stimulation. Each participant will attend three different test sessions in a random order:
  • rTMS targeting Lobule VIII
  • rTMS targeting CRUS I/II
  • Placebo (Sham) stimulation that looks and feels like the real thing but does not affect the brain. During each session, researchers will use brain imaging (fMRI) and computerized tasks to measure changes in brain connectivity and performance in motor and cognitive activities. There is no direct medical benefit to the participants. However, the results will help scientists create better therapies for patients with brain-related health issues The risks are considered minimal. Common side effects of rTMS include temporary mild headaches or a clicking sound during stimulation. MRI scans can sometimes cause mild discomfort or a feeling of closed-in spaces (claustrophobia). Researchers have put safety measures in place, such as hearing protection and constant medical supervision during scans, to minimize these risks.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P50-P75 for not_applicable healthy

Timeline
41mo left

Started Sep 2026

Longer than P75 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 17, 2026

Completed
14 days until next milestone

First Posted

Study publicly available on registry

May 1, 2026

Completed
4 months until next milestone

Study Start

First participant enrolled

September 1, 2026

Expected
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 2, 2030

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 2, 2030

Last Updated

May 1, 2026

Status Verified

April 1, 2026

Enrollment Period

3.3 years

First QC Date

April 17, 2026

Last Update Submit

April 27, 2026

Conditions

Keywords

Repetitive Transcranial Magnetic Stimulation (rTMS)CerebellumLobule VIIICrus I/IIResting-state functional Magnetic Resonance Imaging (rs-fMRI)NeuromodulationNeuroplasticityExcitatory vs. Inhibitory StimulationNeurotypical

Outcome Measures

Primary Outcomes (1)

  • Change in Resting-State Functional Connectivity (RSFC) Measured by functional Magnetic Resonance Imaging (fMRI, expressed as Fisher's z-transformed correlation coefficients) within Cerebellar-Thalamo-Frontal and Cerebellar-Parieto-Motor Networks.

    Functional imaging data will be pre-processed according to standard procedures: slice-timing correction, intra-run spatial realignement, inter-run realignement, distortion and motion artifact correction, band-pass filtering to remove physiological noise, and normalization into the MNI common space, followed by smoothing using FSL and SPM12 software.Subsequently, the signal within the networks of interest will be extracted using the "Conn" toolbox and compared using a General Linear Model (GLM). Connectivity maps will be generated from specific "seed" regions of interest (Crus I/II and lobule VIII), where each voxel value corresponds to the correlation with the seed region.

    Baseline (Pre-stimulation) and 1-hour post-stimulation

Study Arms (12)

1 - Lobule VIII - Crus I/II - Sham Sequence - Excitatory

EXPERIMENTAL

Participants receive active rTMS to Lobule VIII in the first session, followed by active rTMS to Crus I/II in the second, and Sham stimulation in the third.

Device: Active rTMS - Lobule VIIIDevice: Active rTMS - Crus I/IIDevice: Sham rTMSBehavioral: Cognitive and Motor Assessment Battery

2 - Lobule VIII - Sham - Crus I/II Sequence - Excitatory

EXPERIMENTAL

Participants receive active rTMS to Lobule VIII, followed by Sham stimulation, and finally active rTMS to Crus I/II.

Device: Active rTMS - Lobule VIIIDevice: Active rTMS - Crus I/IIDevice: Sham rTMSBehavioral: Cognitive and Motor Assessment Battery

3 - Crus I/II - Lobule VIII - Sham Sequence - Excitatory

EXPERIMENTAL

Participants receive active rTMS to Crus I/II, followed by active rTMS to Lobule VIII, and finally Sham stimulation.

Device: Active rTMS - Lobule VIIIDevice: Active rTMS - Crus I/IIDevice: Sham rTMSBehavioral: Cognitive and Motor Assessment Battery

4 - Crus I/II - Sham - Lobule VIII Sequence - Excitatory

EXPERIMENTAL

Participants receive active rTMS to Crus I/II, followed by Sham stimulation, and finally active rTMS to Lobule VIII.

Device: Active rTMS - Lobule VIIIDevice: Active rTMS - Crus I/IIDevice: Sham rTMSBehavioral: Cognitive and Motor Assessment Battery

5 - Sham - Lobule VIII - Crus I/II Sequence - Excitatory

EXPERIMENTAL

Participants receive Sham stimulation first, followed by active rTMS to Lobule VIII and active rTMS to Crus I/II.

Device: Active rTMS - Lobule VIIIDevice: Active rTMS - Crus I/IIDevice: Sham rTMSBehavioral: Cognitive and Motor Assessment Battery

6 - Sham - Crus I/II - Lobule VIII Sequence - Excitatory

EXPERIMENTAL

Participants receive Sham stimulation first, followed by active rTMS to Crus I/II and active rTMS to Lobule VIII

Device: Active rTMS - Lobule VIIIDevice: Active rTMS - Crus I/IIDevice: Sham rTMSBehavioral: Cognitive and Motor Assessment Battery

1 - Lobule VIII - Crus I/II - Sham Sequence - inhibitory

EXPERIMENTAL
Device: Active rTMS - Lobule VIIIDevice: Active rTMS - Crus I/IIDevice: Sham rTMSBehavioral: Cognitive and Motor Assessment Battery

2 - Lobule VIII - Sham - Crus I/II Sequence - inhibitory

EXPERIMENTAL
Device: Active rTMS - Lobule VIIIDevice: Active rTMS - Crus I/IIDevice: Sham rTMSBehavioral: Cognitive and Motor Assessment Battery

3 - Crus I/II - Lobule VIII - Sham Sequence - inhibitory

EXPERIMENTAL
Device: Active rTMS - Lobule VIIIDevice: Active rTMS - Crus I/IIDevice: Sham rTMSBehavioral: Cognitive and Motor Assessment Battery

4 - Crus I/II - Sham - Lobule VIII Sequence - Inhibitory

EXPERIMENTAL
Device: Active rTMS - Lobule VIIIDevice: Active rTMS - Crus I/IIDevice: Sham rTMSBehavioral: Cognitive and Motor Assessment Battery

5 - Sham - Lobule VIII - Crus I/II Sequence - Inhibitory

EXPERIMENTAL
Device: Active rTMS - Lobule VIIIDevice: Active rTMS - Crus I/IIDevice: Sham rTMSBehavioral: Cognitive and Motor Assessment Battery

6 - Sham - Crus I/II - Lobule VIII Sequence - Inhibitory

EXPERIMENTAL
Device: Active rTMS - Lobule VIIIDevice: Active rTMS - Crus I/IIDevice: Sham rTMSBehavioral: Cognitive and Motor Assessment Battery

Interventions

Either excitatory (e.g., iTBS) or inhibitory (e.g., cTBS) depending on the assigned group.

1 - Lobule VIII - Crus I/II - Sham Sequence - Excitatory1 - Lobule VIII - Crus I/II - Sham Sequence - inhibitory2 - Lobule VIII - Sham - Crus I/II Sequence - Excitatory2 - Lobule VIII - Sham - Crus I/II Sequence - inhibitory3 - Crus I/II - Lobule VIII - Sham Sequence - Excitatory3 - Crus I/II - Lobule VIII - Sham Sequence - inhibitory4 - Crus I/II - Sham - Lobule VIII Sequence - Excitatory4 - Crus I/II - Sham - Lobule VIII Sequence - Inhibitory5 - Sham - Lobule VIII - Crus I/II Sequence - Excitatory5 - Sham - Lobule VIII - Crus I/II Sequence - Inhibitory6 - Sham - Crus I/II - Lobule VIII Sequence - Excitatory6 - Sham - Crus I/II - Lobule VIII Sequence - Inhibitory

Participants receive rTMS targeting the Crus I/II of the cerebellum. Either excitatory (e.g., iTBS) or inhibitory (e.g., cTBS) depending on the assigned group.

1 - Lobule VIII - Crus I/II - Sham Sequence - Excitatory1 - Lobule VIII - Crus I/II - Sham Sequence - inhibitory2 - Lobule VIII - Sham - Crus I/II Sequence - Excitatory2 - Lobule VIII - Sham - Crus I/II Sequence - inhibitory3 - Crus I/II - Lobule VIII - Sham Sequence - Excitatory3 - Crus I/II - Lobule VIII - Sham Sequence - inhibitory4 - Crus I/II - Sham - Lobule VIII Sequence - Excitatory4 - Crus I/II - Sham - Lobule VIII Sequence - Inhibitory5 - Sham - Lobule VIII - Crus I/II Sequence - Excitatory5 - Sham - Lobule VIII - Crus I/II Sequence - Inhibitory6 - Sham - Crus I/II - Lobule VIII Sequence - Excitatory6 - Sham - Crus I/II - Lobule VIII Sequence - Inhibitory
Sham rTMSDEVICE

The coil looks and sounds identical to the active coil and is placed in the same positions (counterbalanced between Lobule VIII and Crus I/II sites). It provides the physical sensation and auditory "click" of TMS without delivering a significant magnetic field to the brain tissue, maintaining the study's double-blind integrity.

Also known as: Placebo, Sham
1 - Lobule VIII - Crus I/II - Sham Sequence - Excitatory1 - Lobule VIII - Crus I/II - Sham Sequence - inhibitory2 - Lobule VIII - Sham - Crus I/II Sequence - Excitatory2 - Lobule VIII - Sham - Crus I/II Sequence - inhibitory3 - Crus I/II - Lobule VIII - Sham Sequence - Excitatory3 - Crus I/II - Lobule VIII - Sham Sequence - inhibitory4 - Crus I/II - Sham - Lobule VIII Sequence - Excitatory4 - Crus I/II - Sham - Lobule VIII Sequence - Inhibitory5 - Sham - Lobule VIII - Crus I/II Sequence - Excitatory5 - Sham - Lobule VIII - Crus I/II Sequence - Inhibitory6 - Sham - Crus I/II - Lobule VIII Sequence - Excitatory6 - Sham - Crus I/II - Lobule VIII Sequence - Inhibitory

Participants perform three computerized tasks to evaluate the functional impact of the rTMS: * Visuomotor Task: A joystick-based task assessing motor coordination and learning (linked to Lobule VIII). * Temporal Prediction Task: A visual task requiring the participant to predict the timing of an event (linked to Crus I/II). * Mental Imagery \& Finger Tapping: A task assessing the cognitive representation of movement.

1 - Lobule VIII - Crus I/II - Sham Sequence - Excitatory1 - Lobule VIII - Crus I/II - Sham Sequence - inhibitory2 - Lobule VIII - Sham - Crus I/II Sequence - Excitatory2 - Lobule VIII - Sham - Crus I/II Sequence - inhibitory3 - Crus I/II - Lobule VIII - Sham Sequence - Excitatory3 - Crus I/II - Lobule VIII - Sham Sequence - inhibitory4 - Crus I/II - Sham - Lobule VIII Sequence - Excitatory4 - Crus I/II - Sham - Lobule VIII Sequence - Inhibitory5 - Sham - Lobule VIII - Crus I/II Sequence - Excitatory5 - Sham - Lobule VIII - Crus I/II Sequence - Inhibitory6 - Sham - Crus I/II - Lobule VIII Sequence - Excitatory6 - Sham - Crus I/II - Lobule VIII Sequence - Inhibitory

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Subject, male or female, aged between 18 and 60 years inclusive
  • Subject affiliated with or a beneficiary of a social security health insurance scheme
  • Subject has dated and signed the informed consent form prior to the start of any trial-related procedures
  • For women of childbearing potential, a negative urinary pregnancy test and the use of effective contraception throughout the duration of the study

You may not qualify if:

  • Subject with substance use disorders (as defined by the DSM-5)
  • Subject suffering from a neurological pathology or sequelae
  • Subject with Attention-Deficit/Hyperactivity Disorder (ADHD)
  • Subject with Borderline Personality Disorder
  • Subject presenting with disabling sensory impairments, specifically a visual acuity (corrected, if applicable) \< 0.8 (due to the use of visual materials; Freiburg Vision Test, Bach 1996; verified during an examination at the screening visit)
  • Subject deprived of liberty or under legal protection
  • Subject under guardianship or trusteeship
  • Pregnant or breastfeeding woman (verified by a urinary test at the screening visit)
  • Subject presenting a contraindication for fMRI or rTMS: presence of non-removable ferromagnetic bodies, prostheses, pacemakers, implanted medication pumps, vascular clips or stents, heart valves or ventricular shunts, certain intracerebral clips, cochlear implants, history of seizures (epilepsy), or skin breach/pathology at the point of contact with the electrodes
  • Subject with a history of major neurological or psychiatric disease with current psychotropic medication (i.e., antipsychotics, benzodiazepines and related compounds, or hypnotics)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpitaux Universitaires de Strasbourg

Strasbourg, 67091, France

Location

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Only the personnel specifically operating the rTMS platform will have knowledge of the type of stimulation (active target VIII, active target Crus I/II, or Sham) being administered to each participant. This ensures that both the volunteer and the research team evaluating the behavioral and imaging data remain unaware of the intervention assignment until the end of the analysis phase.
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 17, 2026

First Posted

May 1, 2026

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

January 2, 2030

Study Completion (Estimated)

January 2, 2030

Last Updated

May 1, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations